Health Parameters in Soccer Players and Sedentary Individuals After Consuming a Synbiotic

Not Applicable

Completed

• Conditions: Sedentary Behavior; Athlete
• Interventions: Dietary Supplement: Placebo; Dietary Supplement: Synbiotic complement

• Registration Number: NCT04776772
• Lead Sponsor: Catholic University of Murcia

Brief Summary

The main objective of this research was to carry out an experimental study, triple blind, on the possible immunophysiological effects of a nutritional supplement (Synbiotic, Gasteel Plus®, Heel España S.A.U.), containing a mixture of probiotic strains, such as Bifidobacterium lactis CBP-001010, Lactobacillus rhamnosus CNCM I-4036, Bifidobacterium longum ES1, as well as prebi-otic fructooligosaccharides, in both professional athletes and sedentary people. The effects on some inflammatory/immune (IL-1β, IL-10, and immunoglobulin A) and stress (epinephrine, nore-pinephrine, dopamine, serotonin, CRH, ACTH, and cortisol) biomarkers were evaluated, determined by flow cytometer and ELISA. The effects on metabolic profile and physical activity, as well as on various parameters that could affect physical and mental health, were also evaluated via the use of accelerometry and validated questionnaires.

Detailed Description

This investigation was a triple blinded, randomized, placebo-controlled pilot study designed to identify the possible differing effects of the synbiotic Gasteel Plus® supplementation.

The participants were professional soccer players of the Second Division B of the Spanish League and sedentary students of the same sex and age range. Both study groups were randomly divided into two groups: a control group administered with placebo, and an experimental group administered with the synbiotic. Each participant was evaluated at baseline, as well as after the intervention which lasted one month. Only in the athletes group did the synbiotic intervention clearly improve objective physical activ-ity and sleep quality, as well as perceived general health, stress, and anxiety levels.

Study Timeline

• Study Start: 2019-05-15
• Primary Completion: 2019-06-16
• Study Completion: 2019-06-30
• Status Verified: 2021-02
• Study First Submitted: 2021-02-08
• Study First Submitted QC: 2021-02-25
• Last Update Submitted: 2021-02-25
• Study First Posted: 2021-03-02
• Last Update Posted: 2021-03-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 27

Inclusion Criteria

• Sedentary individuals: students with low levels of physical activity (≤ 150 minutes/week),
• Athletes: semi professional soccer players

Exclusion Criteria

• Participants were prohibited from consuming probiotics, prebiotics or fermented products (yogurt or other foods)
• Presenting injury or illness

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Soccer player placebo	Placebo	Soccer player consuming placebo sticks filled with 300 mg excipient of maltodextrin
Soccer player synbiotic	Synbiotic complement	Soccer players consuming a mixture of probiotic strains: Bifidobacterium lactis CBP-001010, Lactobacillus rhamno-sus CNCM I-4036, Bifidobacterium longum ES1 and fructooligosaccharides (200 mg) as a prebiotic
Sedentary individuals placebo	Placebo	Sedentary individuals consuming placebo sticks filled with 300 mg excipient of maltodextrin
Sedentary individuals synbiotic	Synbiotic complement	Sedentary individuals consuming a mixture of probiotic strains: Bifidobacterium lactis CBP-001010, Lactobacillus rhamno-sus CNCM I-4036, Bifidobacterium longum ES1 and fructooligosaccharides (200 mg) as a prebiotic

Primary Outcome Measures

Name	Time	Method
Questionnarie about perceived depression	One day after the ingestion of the synbiotic or placebo	Beck´s Depression Inventory: Scale from 0 to 63. Higher scores mean a worse outcome.
Determination of the adrenocorticotropic hormone (ACTH) (Blood sampling)	One day after the ingestion of the synbiotic or placebo	Analyzed by competitive inhibition enzyme immunoassays (ELISA), using The Human ACTH (Adrenocorticotropic Hormone) ELISA Kit (Elabscience, USA).; Measured in pg/ml.
Determination of the corticotropin-releasing hormone (CRH) (Blood sampling)	One day after the ingestion of the synbiotic or placebo	Analyzed by competitive inhibition enzyme immunoassays (ELISA), using The Human Corticotropin Releasing Hormone (CRH) RD-CRH-Hu (Kelowna, BC, V1W 4V3, Canada) Measured in pg/ml.
Determination of the stress hormones serotonin (Blood sampling)	One day after the ingestion of the synbiotic or placebo	Analyzed by competitive inhibition enzyme immunoassays (ELISA), using The General 5-Hydroxytryptamine (5-HT) RD-5-HT-Ge.; Measured in ng/ml.
Determination of the stress hormones Cortisol (Blood sampling)	One day after the ingestion of the synbiotic or placebo	Analyzed by competitive inhibition enzyme immunoassays (ELISA), using The DetectX Cortisol Immunoassay Kit.; Measured in µg/dl.
Questionnarie about anxiety levels (personality)	One day after the ingestion of the synbiotic or placebo	The Trait Anxiety Inventory (STAI): Scale from 0 to 60. Higher scores mean a worse outcome.
Determination of the anti-inflammatory cytokine IL-10 (Blood sampling)	One day after the ingestion of the synbiotic or placebo	Using the LuminexTM 200 System instrument (Luminex Corporation, Texas, USA) using the ProcartaPlex TM Multiplex Immunoassay for analysis.; Measured in pg/ml.
Objective determination of levels of physical activity, sedentary lifestyle and sleep quality: accelerometry	During 7 days after the ingestion of the synbiotic or placebo	Participants wore the accelerometer held with an elastic band on the non-dominant wrist for 7 consecutive days and without interruption, except for those times of the day in which the correct operation of the device could be compromised (showers or any activity related to wa-ter). Subsequently, the files generated by the accelerometer were analyzed through a specific software called Actilife 6 (Actigraph, Pensacola, USA).
Questionnarie about general health.	One day after the ingestion of the synbiotic or placebo	SF-36 Questionnaire: Scale from 0 to 100. Higher scores mean a better outcome.
Questionnarie about perceived stress	One day after the ingestion of the synbiotic or placebo	The Perceived Stress Scale: Scale from 0 to 56. Higher scores mean a worse outcome.
Determination of the catecholamine epinephrine (Blood sampling)	One day after the ingestion of the synbiotic or placebo	Analyzed by competitive inhibition enzyme immunoassays (ELISA), using The General Epinephrine (EPI) RD-EPI-Ge-96T.; Measured in pg/ml.
Determination of the catecholamine norepinephrine (Blood sampling)	One day after the ingestion of the synbiotic or placebo	Analyzed by competitive inhibition enzyme immunoassays (ELISA), using The General Noradrenaline (NE) RD-NE-Ge-96T.; Measured in pg/ml.
Determination of glucose levels (metabolic profile)	One day after the ingestion of the synbiotic or placebo	The determinations for obtaining the glycemic profile were carried out through standard techniques with the automatic analyzer of clinical chemistry BA 400 (BioSystems) in the SYNLAB laboratories (Diagnosticos Globales S.A.U., Badajoz, Spain).; Measured in mg/dl
Questionnarie about anxiety levels (moment)	One day after the ingestion of the synbiotic or placebo	The State Anxiety Inventory (STAI): Scale from 0 to 60. Higher scores mean a worse outcome.
Questionnarie about sleep quality	One day after the ingestion of the synbiotic or placebo	Healthy Lifestyle and Personal Control Questionnaire: Scale from -1 to 10. Higher scores mean a better outcome.
Questionnarie about perceived fatigue	One day after the ingestion of the synbiotic or placebo	Brief Fatigue Inventory: Scale from 0 to 40. Higher scores mean a worse outcome.
Determination of the pro-inflammatory cytokine IL-1β (Blood sampling)	One day after the ingestion of the synbiotic or placebo	Using the LuminexTM 200 System instrument (Luminex Corporation, Texas, USA) using the ProcartaPlex TM Multiplex Immunoassay for analysis.; Measured in pg/ml.
Determination of the catecholamine dopamine (Blood sampling)	One day after the ingestion of the synbiotic or placebo	Analyzed by competitive inhibition enzyme immunoassays (ELISA), using The Dopamine Research Immunoassay Measured in ng/ml.
Determination of the immunoglobulin A (Saliva sampling)	One day after the ingestion of the synbiotic or placebo	Analyzed by indirect enzyme immunoassay kit through the Salivary Secretory IgA Kit (Salimetrics LLC, USA). The procedures followed the instructions of the manufacturers, and the findings were measured using an ELISA auto analyzer to quantify color intensity (Sunrise, Tecan, Männendorf, Switzerland).; Measured in µg/ml
Determination of total cholesterol levels (metabolic profile)	One day after the ingestion of the synbiotic or placebo	The determinations for obtaining the lipid profile were carried out through standard techniques with the automatic analyzer of clinical chemistry BA 400 (BioSystems) in the SYNLAB laboratories (Diagnosticos Globales S.A.U., Badajoz, Spain).; Measured in mg/dl
Determination of the triglycerides levels (metabolic profile)	One day after the ingestion of the synbiotic or placebo	The determinations for obtaining the lipid profile were carried out through standard techniques with the automatic analyzer of clinical chemistry BA 400 (BioSystems) in the SYNLAB laboratories (Diagnosticos Globales S.A.U., Badajoz, Spain).; Measured in mg/dl

Trial Locations

Locations (1)

Catholic University of Murcia; 🇪🇸 Murcia, Spain